Use of a sprayable composition comprising ambroxol

Patent metadata

Field	Value
Publication number	US-10959964-B2
Application number	US-201214003375-A
Country	US
Kind code	B2
Filing date	Mar 13, 2012
Priority date	Mar 14, 2011
Publication date	Mar 30, 2021
Grant date	Mar 30, 2021

Abstract

The present invention relates to ambroxol hydrochloride for the treatment of acute pharyngitis, wherein ambroxol hydrochloride as a sprayable composition comprising up to 30 mg/ml ambroxol hydrochloride is administered locally in a dose of 1 to 20 mg.

First claim

The invention claimed is:

1. A method of treating acute pharyngitis, the method comprising:
administering a sprayable composition of ambroxol hydrochloride to a subject with an applicator device such that the sprayable composition is delivered uniformly and locally to only an inflamed region of the oropharynx of the subject without the tongue and other parts of the oral and pharyngeal cavity coming into contact with the sprayable composition, the sprayable composition comprising ambroxol hydrochloride in an amount of 17.86 mg/ml to 30 mg/ml, ethanol, a polysorbate in an amount from 0.05 to 0.5% by weight of the sprayable compostion, a pH-regulating substance to regulate the pH of the sprayable composition within a range of 5.2 to 5.8, a sweetener, and water in an amount of at least 85% by weight of the sprayable composition;
wherein two or four sprays from the applicator device provides a dosage of 10 mg ambroxol hydrochloride administered locally to the subject.

2. The method according to claim 1 , wherein the sprayable composition has a viscosity in the range from 1.4 to 1.6 mPa*s.

3. A method of treating acute pharyngitis, the method comprising:
administering a sprayable composition of ambroxol hydrochloride to a subject with an applicator device such that the sprayable composition is delivered uniformly and locally to only an inflamed region of the oropharynx of the subject without the tongue and other parts of the oral and pharyngeal cavity coming into contact with the sprayable composition, the sprayable composition comprising ambroxol hydrochloride in an amount of 17.86 mg/ml, ethanol, a polysorbate in an amount from 0.05 to 0.5% by weight of the sprayable compostion, a pH-regulating substance to regulate the pH of the sprayable composition within a range of 5.2 to 5.8, a sweetener, and water in an amount of at least 85% by weight of the sprayable composition;
wherein two or four sprays from the spray applicator provides a dosage of 10 mg ambroxol hydrochloride, administered locally to the subject.

4. An applicator device comprising a spray applicator and a container containing a sprayable composition, wherein the sprayable composition consists of:
ambroxol hydrochloride in an amount of 17.86 mg/ml to 30 mg/ml;
ethanol;
a polysorbate in an amount from 0.05 to 0.5% by weight of the sprayable compostion;
a pH-regulating substance to regulate the pH of the sprayable composition within a range of 5.2 to 5.8;
a sweetener; and
water in an amount of at least 85% by weight of the sprayable composition;
wherein two or four sprays from the spray applicator provides a dosage of 10 mg ambroxol hydrochloride administered locally to the subject, and the sprayable composition is delivered by the applicator device uniformly and locally to only an inflamed region of the oropharynx of the subject without the tongue and other parts of the oral and pharyngeal cavity coming into contact with the sprayable composition.

5. The application device of claim 4 , wherein the amount of ambroxol hydrochloride in the sprayable composition is 17.86 mg/ml.

Assignees

• Sauerland Sandra
• Boni Julia Elisabeth
• Plohmann Bernd Karl
• Sanofi Aventis Deutschland

Inventors

• Sauerland Sandra
• Boni Julia Elisabeth
• Plohmann Bernd Karl

Classifications

• A61K9/0073

  Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy; (nasal sprays A61K9/0043; inhalation of vapours of volatile or heated drugs, e.g. essential oils or nicotine, A61K9/007; devices A61M) · CPC title

• A61K9/006

  Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays · CPC title

• A61P11/04

  for throat disorders · CPC title

• A61K31/137 Primary

  Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine {or methadone} · CPC title

• A61P1/02

  Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis · CPC title